WithdrawnNot Applicable

Evidence-Based Osteopathy for Tension-Type Headache (EBOTTH)

Stopped: Problems for satellite centers in obtaining ethical clearance.

0Started 2016-01

Plain-language summary

Tension-type headache (TTH) is a very common primary headache disorder, with important costs for both patients and society. Often these patients are not willing to take prophylactic medications and resort to complementary therapies. Osteopathic manipulative treatment (OMT) is an interesting option in such field, since it is characterized by a low profile of side effects. In this study the investigators will assess the efficacy of OMT (semi-structured evaluation and "black box" treatment) in frequent Episodic TTH (ETTH) in an outpatient setting. Preliminary data for power calculation are already available (Rolle et al. 2014), and the investigators plan to recruit 264 ETHH patients by a multicentric, randomized, double-blind, sham-controlled design.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age ≥18 and ≤65 years-old, * diagnosis of frequent episodic tension-type headache according to the International Headache Society guidelines, * frequency of attacks ≥3/month, * willing to adhere to study procedures, * signed informed consent Exclusion Criteria: * age \<18 or \>65 years-old, * headache duration less than one year, * history of: major psychiatric disorders, relevant cognitive deficits, chronic pain other than headache, secondary headaches, * any type of headache prophylactic treatment ongoing or started during the study, * hormonal therapy started or modified during the study, * participating to other clinical trials, * not willing to sign informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Headache frequency

Timeframe: 4 months

Trial details

NCT IDNCT02592850

SponsorUniversity of Milano Bicocca

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06

View on ClinicalTrials.gov More Tension-Type Headache trials